Actively Recruiting
Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System
Led by Massachusetts General Hospital · Updated on 2025-10-22
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new tethered capsule endomicroscopy (TCE) imaging system designed to capture detailed images of the esophagus using optical frequency domain imaging (OFDI). This pilot study includes healthy volunteers and participants diagnosed with Barrett's Esophagus (BE) to assess the safety, ease of use, and feasibility of this compact imaging technology in preparation for a larger clinical trial. The study involves inserting a small capsule attached to a string-like tether into the esophagus. The tether allows the operator to control and guide the capsule as it moves down the esophagus via natural swallowing motions. Imaging is performed in real time using the compact OFDI system, and the images are later analyzed to evaluate the device's performance. Participants will undergo imaging sessions lasting about 5 to 7 minutes. The study team will assess the quality and performance of the compact imaging system during this period. Participants must avoid solid food for 4 hours and only consume clear liquids for 2 hours before the procedure. The total participation duration and follow-up details are based on the imaging and safety assessments conducted during the study.
CONDITIONS
Brief Title
Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A previous diagnosis of Barrett's Esophagus (not required for healthy volunteers)
- Participants 18 years and older with a previous diagnosis of GERD
- Participants 14 years and older with a previous diagnosis of EoE (not required for healthy volunteers)
- Healthy participants over age 18 and under 85 years
- Participants must be able to give informed consent
- Participants must have no solid food for 4 hours and only clear liquids for 2 hours before the procedure
You will not qualify if you...
- Participants over 85 years old
- Participants unable to swallow pills or capsules
- Participants with a strong gag reflex
- Participants with esophageal fistula or strictures smaller than the capsule diameter
- Pregnant participants or women of childbearing age who test positive or are unsure about pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 5 to 7 minutes
Participants undergo imaging of the esophagus using a tethered OFDI capsule with a compact imaging system. The capsule is controlled as it moves down the esophagus to acquire real-time images for later analysis.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Massachusetts General hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
J
Juleen Guoy, RN
A
Anita Chung, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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